Suit filed against device maker, hospital in York infection death case

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YORK, Pa. – A lawsuit has been filed against York Hospital, and the manufacturer of a heater-cooler device, which is believed to have spread an infection that resulted in a patient’s death. The device is used in open-heart surgeries.

The suit was filed on behalf of David Inners, 62, of York, who was admitted to the hospital in December 2014. Inners contracted nontuberculous myobacteria, or NTM, while undergoing open-heart and aortic valve surgery. He endured subsequent months of fever and fatigue. Later, he suffered renal failure and congestive heart failure, until he died almost 11 months after his operation.

In the fall of 2015, York Hospital, owned by WellSpan Health, notified 1,300 patients, who had open-heart surgery between Oct. 1, 2011 and July 21, 2015. According to reports, York Hospital also contacted Inners. Hospital officials wanted patients to know that they may have been exposed to NTM, as a result of problems with the heater-cooler device made by a subsidiary of London-based LivaNova, PLC.

Five York Hospital patients have died. Three other patients have been diagnosed with NTM.

The Milton Hershey Medical Center also gave notice to 2,300 patients after at least two died from NTM infections. Similar cases have been investigated in other states, including South Carolina and Iowa.

The infection is slow moving and patients who contracted NTM could take months or even years to develop symptoms.

The medical device – a Sorin 3T Heater-Cooler System, named for the LivaNova subsidiary — are used during surgery to control a patient’s body temperature. But, because of a defect in the heater-cooler device, NTM could develop in the machines, and then become “aerosolized” by the device and could enter a patient’s body.

The manufacturer in July 2014 – seven months after Inners’ surgery – sent an “Important Information” letter to hospitals noting that its own investigations had found that some devices were contaminated and warned that without proper cleaning, disinfection and maintenance the NTM bacteria “can multiply” in a heater-cooler device. The lawsuit filed on behalf of Inners’ estate claims that not only was the device defective but also that LivaNova knew or should have known of the association of the device and NTM infections based on its own investigation and, or testing.

The lawsuit also claims that WellSpan York Hospital was negligent in its maintenance and cleaning of the device and in failing to earlier warn exposed patients of their risk of NTM infections.

Wellspan issued the following statement:
“We do not comment on active or pending litigation. That said, our focus continues to be on ensuring our patients get all the information, care and treatment they need related to this issue.

The safety, health and well-being of our patients is our highest priority.

That is why we acted swiftly and responsibly to protect patient safety, upon first identifying this as an issue. And it is why we have provided comprehensive health care resources for the 1,300 individuals who may have been potentially exposed to this bacteria. These resources include a toll-free nurse call center, a dedicated website with updated information and a specialized clinic for follow-up care.

WellSpan is committed to providing reliably safe and exceptional care to every patient, every time.”

SOURCE: Kline & Specter PC